Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021386586

FEI Number

3021386586

Entity Name

LINCOTEK (WUXI) CO., LTD.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

Block G, No. 30 Wanquan Road, Yunlin, Xishan District, Wuxi Jiangsu 214192, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lincotek (Wuxi) Co., Ltd. (Owner Number: 10083716)

Owner / Operator Contact Address

Block G, No. 30 Wanquan Road, Yunlin, Xishan District, Wuxi, CN-JS 214192, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-12-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2021-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Lincotek (Wuxi) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Similar Registrations

Registration Number	Establishment Name	Location
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3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3005562917	BGS Beta-Gamma-Service GmbH & Co KG	Bruchsal Baden-Wurttemberg, DE
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
3020155054	SHALBY ADVANCED TECHNOLOGIES, INC.	El Dorado Hills, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021386586. Last updated year: 2026. Please use registration number 3021386586 when referencing this establishment in official correspondence.